[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598209":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":55,"collaborators":58,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":26,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":26,"overallStatus":82,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Zhejiang Cancer Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Chemotherapy","PLACEBO_COMPARATOR","Received placebo combined with investigator's choice of chemotherapy (either SOX or CAPOX regimen",[13],"Drug: SOX or CAPOX regimen",{"label":15,"type":16,"description":17,"interventionNames":18},"Chemotherapy and immunotherapy","EXPERIMENTAL","Received tislelizumab combined with investigator's choice of chemotherapy (SOX or CAPOX regimen",[19,13],"Drug: Tislelizumab",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Tislelizumab","Received tislelizumab combined with investigator's choice of chemotherapy",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"SOX or CAPOX regimen","chemotherapy (SOX or CAPOX regimen)",[9,15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Xiangdong Cheng","CONTACT","0086-571-881280","Chengxd516@126.com",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Can Hu","13968032995","chengxd@zjcc.org.cn",[42],{"facility":43,"status":26,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":26},"Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)","Hangzhou","Zhejiang","310000","China","CN",{"type":50,"coordinates":51},"Point",[52,53],120.16142,30.29365,{"lat":53,"lon":52},{"type":56,"investigatorFullName":33,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Principal Investigator",[59,61],{"name":60,"class":6},"Sichuan Cancer Hospital and Research Institute",{"name":62,"class":6},"Liaoning Cancer Hospital & Institute","100598209","phase-3-perioperative-tislelizumab-plus-chemotherapy-versus-chemotherapy-alone-in-mhc-ii-positive-gastricgej-cancer-100598209",false,"NCT07068516","Perioperative Tislelizumab Plus Chemotherapy Versus Chemotherapy Alone in MHC-II-Positive Gastric\u002FGEJ Cancer","A Multicenter, Randomized, Double-blind, Phase III Clinical Trial of Tislelizumab Combined With Chemotherapy Versus Placebo Plus Chemotherapy as Perioperative Treatment for MHC Class II-positive Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Willingness to participate and signed informed consent form\n* ≥18 years old\n* Histologically confirmed gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma\n* MHC-II immunohistochemistry (IHC) 2+\u002F3+\n* Locally advanced disease (cT3-4a, N+, M0) confirmed by CT and\u002For diagnostic laparoscopy (AJCC 8th edition)\n* No previous anticancer therapy (surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.)\n* Scheduled to undergo curative resection after neoadjuvant therapy\n* Ability to swallow oral medication\n* ECOG performance status 0-1\n* Estimated survival ≥6 months\n* Hematological (without transfusion\u002FG-CSF support within 14 days):ANC ≥1.5×10⁹\u002F, Platelets ≥80×10⁹\u002FL, Hemoglobin ≥80 g\u002FL. Hepatic\u002FRenal: Total bilirubin \\\u003C1.5×ULN, ALT\u002FAST ≤2.5×ULN, Serum creatinine ≤1.5×ULN or CrCl \\>50 mL\u002Fmin (calculated by Cockcroft-Gault formula: Male: CrCl = \\[(140-age) × weight (kg)\\] \u002F (72 × serum Cr \\[mg\u002FdL\\]), Female: CrCl = \\[(140-age) × weight (kg)\\] \u002F (72 × serum Cr \\[mg\u002FdL\\]) × 0.85.\n* Contraception Requirements: Female participants of childbearing potential: Negative serum pregnancy test within 7 days before enrollment; agreement to use highly effective contraception during treatment and for 120 days after last dose. Female participants of childbearing potential: Negative serum pregnancy test within 7 days before enrollment; agreement to use highly effective contraception during treatment and for 120 days after last dose.\n\nExclusion Criteria:\n\n* Tumors deemed unresectable due to disease extent, surgical contraindications, or patient refusal.\n* Known microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) tumors.\n* History of or concurrent other malignancies (except adequately treated non-melanoma skin cancer or carcinoma in situ).\n* Chronic or clinically significant conditions that may compromise treatment tolerance (e.g., severe cardiac disease, uncontrolled hypertension, significant hepatic\u002Frenal dysfunction).\n* History of gastrointestinal perforation, intra-abdominal abscess, or bowel obstruction within 3 months (or clinical\u002Fradiologic suspicion of obstruction).\n* Presence of active ulcers, non-healing wounds, or fractures.\n* Arterial\u002Fvenous thrombosis within 6 months (e.g., stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism).\n* Urinalysis showing ≥++ protein with confirmed 24-hour urine protein \\>1.0 g.\n* Requiring systemic antibiotics, antivirals, or antifungals.\n* Hepatitis B: HBsAg-positive with HBV DNA ≥500 IU\u002FmL. Hepatitis C: HCV antibody-positive with HCV RNA above ULN.\n* Congenital or acquired (e.g., HIV infection).\n* Active autoimmune disease or history of autoimmune disease with relapse potential.\n* Prior or planned organ\u002Fallogeneic bone marrow transplantation.\n* Interstitial lung disease (ILD), history of steroid-treated ILD, active pneumonia on screening CT, or active tuberculosis.\n* Current or recent use of immunosuppressants or systemic corticosteroids (except physiologic replacement doses).\n* Received live attenuated vaccines within 28 days before treatment or requiring them during\u002Fwithin 60 days post-treatment.\n* Known allergy to any study drug or excipients.\n* Currently breastfeeding.\n* Any condition that, per investigator judgment, may jeopardize patient safety or study completion.","ALL","18 Years","80 Years",{"count":74,"type":75},470,"ESTIMATED","INTERVENTIONAL",[78],"PHASE3","Investigators has conducted a series of studies on patient selection for perioperative immunotherapy in locally advanced gastric cancer. Results from prospective single-arm trial (NCT05739045) demonstrated that 21.74% of patients achieved pathological complete response (pCR) after receiving neoadjuvant nivolumab combined with SOX regimen. Notably, investigators identified that the sensitive group exhibited upregulated MHC-II expression in malignant cells at baseline, with enriched pathways including interferon-gamma signaling and MHC class II antigen presentation. The pCR rate was significantly higher in MHC-II positive patients compared to MHC-II negative patients (36.84% vs 11.11%, P=0.038). Subsequent retrospective analyses and another prospective single-arm study focusing on MHC-II positive populations consistently showed superior short-term treatment outcomes with immunotherapy plus chemotherapy in this subgroup.\n\nBuilding upon these preliminary findings from small-scale studies and considering current developments in the field, we are now initiating this multicenter, randomized, double-blind, placebo-controlled phase III clinical trial. The study aims to evaluate the efficacy and safety of tislelizumab combined with chemotherapy versus placebo plus chemotherapy as perioperative treatment for MHC-II positive patients with locally advanced gastric or gastroesophageal junction adenocarcinoma.",[81],"Gastric Cancer Stage","NOT_YET_RECRUITING","2025-07-06",{"date":85,"type":86},"2025-07-16","ACTUAL",{"date":88,"type":75},"2025-07-20",{"date":90,"type":75},"2030-06-30",{"name":33,"class":6},1]